Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00289913

Purpose

Stage 1: Hepatitis A vaccine will be given either alone or together with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine or Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) at the first dose. A second dose of hepatitis A vaccine will be given 6 months later. Responses to the vaccines and safety data will be collected after each dose. Stage 2: Two (2) doses Hepatitis A vaccine will be administered at least 6 months apart. Safety data will be collected after each dose.

Condition	Intervention	Phase
Hepatitis A Virus	Biological: Comparator: Vaqta Biological: Comparator: Infanrix Biological: Comparator: PedvaxHIB	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open, Rand., Multictr. Study of Safety, Tolerability, & Immunogenicity of Hepatitis A Vaccine, Inactivated Given Concomitantly With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate), Diphtheria, Tetanus Toxoids, and Acellular Pertussis Vaccine Adsorbed in Healthy Children 15 Mos. Old

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis A Tetanus Whooping Cough

Drug Information available for: Tetanus Vaccine Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Antibody response of hepatitis A [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: No ]
Antibody response to Hib and antibody titers for pertussis [ Time Frame: 4 weeks post vaccination ] [ Designated as safety issue: No ]
Safety profile of Hepatitis A Vaccine, Inactivated with other vaccines. Safety profile of Hepatitis A Vaccine, Inactivated after any dose [ Time Frame: 14 days following vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1270
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental VAQTA 0.5 ml injection, Infanrix 0.5 ml injection, PedvaxHIB 0.5 ml injection, VAQTA 0.5 ml injection	Biological: Comparator: Vaqta VAQTA 0.5 ml injection Biological: Comparator: Infanrix Infanrix 0.5 ml injection Biological: Comparator: PedvaxHIB PedvaxHIB 0.5 ml injection
Arm 2: Experimental Infanrix 0.5 ml injection, PedvaxHIB 0.5 ml injection, VAQTA 0.5 ml injection, VAQTA 0.5 ml injection	Biological: Comparator: Vaqta VAQTA 0.5 ml injection Biological: Comparator: Infanrix Infanrix 0.5 ml injection Biological: Comparator: PedvaxHIB PedvaxHIB 0.5 ml injection
Arm 3: Experimental VAQTA 0.5 ml injection, PedvaxHIB 0.5 ml injection, VAQTA 0.5 ml injection	Biological: Comparator: Vaqta VAQTA 0.5 ml injection Biological: Comparator: PedvaxHIB PedvaxHIB 0.5 ml injection
Arm 4: Experimental PedvaxHIB 0.5 ml injection, VAQTA 0.5 ml injection, VAQTA 0.5 ml injection	Biological: Comparator: Vaqta VAQTA 0.5 ml injection Biological: Comparator: PedvaxHIB PedvaxHIB 0.5 ml injection
Arm 5: Experimental VAQTA 0.5 ml injection, VAQTA 0.5 ml injection	Biological: Comparator: Vaqta VAQTA 0.5 ml injection

Eligibility

Ages Eligible for Study:	12 Months to 17 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Stage 1) Healthy males and females 15 months of age with no active liver disease and a negative history of hepatitis A who have been vaccinated against Haemophilus influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases
Stage 2) Healthy males and females 12 to 17 months of age with no active liver disease and a negative history of hepatitis A

Exclusion Criteria:

Stage 1) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, a history of seizure disorder or a neurologic disorder that would contraindicate pertussis vaccine, or a bleeding disorder
Stage 2) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, or a history of bleeding disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289913

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_076
Study First Received:	February 8, 2006
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00289913 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Hepatitis A virus

Additional relevant MeSH terms:

Bacterial Infections
RNA Virus Infections
Liver Diseases
Hepatitis, Viral, Human
Picornaviridae Infections
Diphtheria
Actinomycetales Infections

Hepatitis
Virus Diseases
Gram-Positive Bacterial Infections
Digestive System Diseases
Corynebacterium Infections
Hepatitis A
Enterovirus Infections

ClinicalTrials.gov processed this record on November 22, 2009